Accurate Test of Limb Isometric Strength (ATLIS) in ALS

NCT02374606 | Unknown

• 1 other identifier: Pro00038868
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A strength measurement device called Accurate Test of Limb Isometric Strength (ATLIS) was developed to precisely and conveniently measure static limb strength in patients with ALS. The investigator will compare ATLIS data with data from the commonly used ALS outcomes measure, the ALS Functional Rating Scale-Revised (ALSFRS-R), as well as an exploratory measure, electrical impedance myography (EIM), in a prospective, longitudinal study. Both outcomes measures will be performed on 100 subjects collected preferably at bi-monthly clinic visits during the study period.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

outcomes measures; strength measurement; disease progression

Outcome Measures

Primary Outcomes (1)

• Change in Accurate Test of Limb Isometric Strength (ATLIS) between each visit

  ATLIS measures isometric strength in 12 muscle groups in the arms and legs. The subject is tested seated in a specially designed chairs with adjustable uprights. The subject's limb is placed in a standard position and maximal force is exerted on the wireless load cell fixed to the upright. Strength data is digitally captured and expressed as a percentage of expected normal.

  every 1 to 4 months according to each patient's site visit schedule

Secondary Outcomes (1)

• Change in ALS Functional Rating Scale - Revised (ALSFRS-R) between each visit

  every 1 to 4 months according to each patient's site visit schedule

Other Outcomes (1)

• Exploratory measure: Electrical impedance myography (EIM) data will be compared to ATLIS data.

  every 1 to 4 months according to each patient's site visit schedule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with ALS

You may qualify if:

• Subjects 18 years or older diagnosed with clinically possible, laboratory supported probable, probable or clinically definite ALS according to the World Federation of Neurology Revised El Escorial Criteria.
• Capable of providing informed consent and complying with trial procedures.
• Active movement of at least two limbs at the time of study entry
• Intend to routinely attend clinic for neurological care at the clinical site

You may not qualify if:

• Patients, judged by the site clinical investigator to have medical conditions that may limit their ability to safely exert maximal force using the muscles in their arms and legs will be excluded from this study (e.g. unstable hypertension, significant cardiac disease, significant musculoskeletal disorders, or other medical conditions).
• Patients judged by the site clinical investigator to have significant clinical evidence of unstable medical or psychiatric illness will be excluded.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Disease Progression

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peggy Allred, PT DPT

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Fetterman

CONTACT

310-423-8497; katherine.fetterman@cshs.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Program Administrator/Neuromuscle Program Manager

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 2, 2015
• Study Start: March 1, 2015
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: April 3, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)